GMPs for Early Stage Development Projects

Inside this White Paper

Navigating Good Manufacturing Practices (GMP) compliance during early-stage pharmaceutical development is critical but often misunderstood. This white paper provides a clear, phase-by-phase roadmap for applying Good Manufacturing Practices from non-clinical stages through Phase III trials. It outlines regulatory expectations, industry standards, and FDA-aligned approaches for materials, specifications, documentation, and process validation. Whether you’re managing pre-IND activities or preparing for commercial scale-up, this case study offers valuable guidance on how to maintain product quality, mitigate risk, and streamline development without compromising scientific integrity.